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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04085978
Other study ID # 501938027
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date May 4, 2020
Est. completion date October 12, 2020

Study information

Verified date October 2020
Source Mednax Center for Research, Education, Quality and Safety
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Evaluate if the implementation of a hypoglycemia protocol with glucose gel has reduced the NICU admission rate of neonates with low-acuity neonatal hypoglycemia.


Recruitment information / eligibility

Status Terminated
Enrollment 400
Est. completion date October 12, 2020
Est. primary completion date October 12, 2020
Accepts healthy volunteers No
Gender All
Age group 34 Weeks and older
Eligibility Inclusion Criteria:

- All neonates born at Banner University Hospital during January 01, 2014 - November 30, 2016 and January 01, 2018 - November 30 2018 who qualify for hypoglycemia protocol.

Exclusion Criteria:

- Neonates <34 weeks gestational age or with birth weight less than 2000 grams.

- Infants with serious congenital malformation

- Infants with a terminal disorder.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Banner University Medical Center Phoenix Phoenix Arizona

Sponsors (2)

Lead Sponsor Collaborator
Mednax Center for Research, Education, Quality and Safety Banner University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mean NICU length of stay rounded to the day Mean NICU length of stay rounded to the day 30 days
Primary Mean maximum glucose infusion rate Mean maximum glucose infusion rate 30 days
Secondary Assess for complications - Number of neonates identified to have any type of infection 30 days
Secondary Assess for weight loss - Maximum weight loss as percent below birth weight during NICU admission 30 days
Secondary Evaluate for persistent symptomatic or asymptomatic hypoglycemia Number of neonates with symptomatic hypoglycemia
Number of neonates with asymptomatic hypoglycemia
30 days
Secondary Number of neonates who received formula Time to gain back to birthweight (if occurred while in-house), rounded to day of life 30 days
Secondary Number of neonates with any breastfeeding during hospitalization Time to gain back to birthweight (if occurred while in-house), rounded to day of life 30 days
Secondary Number of neonates with breastfeeding at time of discharge Time to gain back to birthweight (if occurred while in-house), rounded to day of life 30 days
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